← Patent-cliff monitor small molecule WAKIX PITOLISANT HYDROCHLORIDE
Loss of exclusivity February 2033 FDA regulatory exclusivity expiry
Company HARMONY BIOSCIENCES MANAGEMENT INC
Drug detail Brand name WAKIX Active ingredient PITOLISANT HYDROCHLORIDE Strength EQ 17.8MG BASE Dosage form TABLET Route ORAL Modality Small molecule FDA approval August 2019 Marketing status RX
Listed patents Patent Expires Type 8207197 March 2030 substance, product 8486947 September 2029 use U-1102 8354430 February 2026 use U-1102
Regulatory exclusivity Code Expires ODE-519 February 2033 ODE-489 June 2031 ODE-331 October 2027 NPP June 2027 ODE-255 August 2026
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.